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Bupivacaine/Meloxicam Prolonged Release: A Review in Postoperative Pain

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Abstract

Prolonged-release (PR; as ascribed in the EU) or extended-release (as ascribed in the USA) bupivacaine/meloxicam (HTX-011; hereafter referred to as bupivacaine/meloxicam PR; Zynrelef®) is a synergistic fixed-dose combination (FDC) of the local anaesthetic bupivacaine and the NSAID meloxicam. It is approved in the EU and the USA to treat postoperative pain. After needle-free application at the surgical site, the novel polymer technology allows simultaneous diffusion of bupivacaine and meloxicam over 72 h. In clinical trials, bupivacaine/meloxicam PR significantly reduced postoperative pain and opioid consumption relative to bupivacaine hydrochloride (HCl) and placebo in patients undergoing bunionectomy, herniorrhaphy or total knee arthroplasty (TKA). When used as the foundation of a scheduled non-opioid multimodal analgesia (MMA) regimen, bupivacaine/meloxicam PR further improved pain control and reduced the need for opioids following surgery. Bupivacaine/meloxicam PR was generally well tolerated, with a lower incidence of opioid-related adverse events than bupivacaine HCl and placebo. Although additional data would be beneficial, current evidence indicates that bupivacaine/meloxicam PR is a promising non-opioid treatment option for the management of postoperative pain.

Plain Language Summary

Poorly managed pain after surgery can lead to decreased quality of life, longer recovery time and a higher risk of complications. Perioperative local anaesthetics are commonly used to manage postoperative pain, but these drugs have a short duration of action. Bupivacaine/meloxicam PR (Zynrelef®) is a long-acting FDC of the local anaesthetic bupivacaine and the NSAID meloxicam approved for the treatment of postoperative pain. Following application without a needle into the surgical site, the active ingredients are simultaneously released for ≈ 3 days. Bupivacaine/meloxicam PR significantly reduced postoperative pain and opioid consumption and increased the proportion of opioid-free patients following bunionectomy, herniorrhaphy and TKA. When used as the foundation of a scheduled non-opioid MMA regimen, bupivacaine/meloxicam PR further reduced pain and the need for opioids. Bupivacaine/meloxicam PR had a similar tolerability profile to those of bupivacaine hydrochloride and placebo, with a lower incidence of opioid-related adverse events. Bupivacaine/meloxicam PR is a promising non-opioid treatment option for managing postoperative pain.

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Acknowledgements

During the peer review process, the manufacturer of bupivacaine/meloxicam PR was also offered an opportunity to review this article. Changes resulting from comments received were made on the basis of scientific and editorial merit.

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  1. Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand

    Hannah A. Blair

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  1. Hannah A. Blair
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Correspondence to Hannah A. Blair.

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The preparation of this review was not supported by any external funding.

Authorship and Conflict of interest

Hannah Blair is a salaried employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to the review and are responsible for the article content.

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Not applicable.

Additional information

The manuscript was reviewed by: J. F. Dasta, The Ohio State University, College of Pharmacy, Columbus, OH, USA; R. Sabatowski, Pain Center, University Hospital Carl Gustav Carus, Technical University Dresden, Dresden, Germany.

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Blair, H.A. Bupivacaine/Meloxicam Prolonged Release: A Review in Postoperative Pain. Drugs 81, 1203–1211 (2021). https://doi.org/10.1007/s40265-021-01551-9

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